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Genetics of Middle Ear Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00422136
First Posted: January 15, 2007
Last Update Posted: November 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Margaretha Casselbrant, Children's Hospital of Pittsburgh
  Purpose
The goal of this study is to identify the genes that contribute to susceptibility to recurrent/persistent middle ear disease. Five hundred families with at least 2 children who have undergone tympanostomy tube insertion will be enrolled. A blood sample will be obtained from the children who had tubes and any available parent (at least 1), as well as any siblings without significant histories of middle ear disease.

Condition
Otitis Media

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Genetic Epidemiology of Otitis Media

Resource links provided by NLM:


Further study details as provided by Margaretha Casselbrant, Children's Hospital of Pittsburgh:

Biospecimen Retention:   Samples With DNA
Blood samples, DNA

Enrollment: 2121
Study Start Date: July 2002
Study Completion Date: July 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:
Using the twin study approach, the investigators demonstrated that time with middle ear effusion (MEE), number of episodes of MEE and numbers of episodes of acute otitis media (AOM) have a strong genetic component. The point estimate of heritability of time with MEE was 0.73. While there is significant evidence that susceptibility to recurrent/persistent OM is largely genetically determined, the specific genes which confer susceptibility are unknown. The overall research strategy to identify genes underlying OM is to apply a three-stage study design that will allow the investigators to balance cost efficiency with statistical power. Five hundred evaluable pairs of siblings with a history of tympanostomy tube insertion (affected), their parent(s) and available non-affected full siblings will be recruited. A blood sample will be obtained from each subject for genotyping.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Families with 2 or more full sibs who had tympanostomy tubes inserted
Criteria

Inclusion Criteria:

  • families: 2 or more full sibs who had tympanostomy tubes inserted

Exclusion Criteria:

  • major congenital malformations
  • medical conditions with a predisposition for OM (e.g. cleft palate, Down syndrome, or other craniofacial malformations
  • cared for in the Intensive Care Unit as neonate
  • been on assisted ventilation
  • known sensorineural hearing loss
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422136


Locations
United States, Pennsylvania
ENT Research Center, Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
University of Pittsburgh
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Margaretha L Casselbrant, MD, PhD University of Pittsburgh
  More Information

Publications:
Responsible Party: Margaretha Casselbrant, Principal Investigator, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier: NCT00422136     History of Changes
Other Study ID Numbers: R01DC005630 ( U.S. NIH Grant/Contract )
First Submitted: January 12, 2007
First Posted: January 15, 2007
Last Update Posted: November 15, 2011
Last Verified: November 2011

Keywords provided by Margaretha Casselbrant, Children's Hospital of Pittsburgh:
middle ear
otitis
genetics

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases